Monitoring small kidney tumors without immediate surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational, multi-national study aims to evaluate the overall survival of patients diagnosed with small renal cell carcinoma (RCC) measuring less than 4 cm, who are managed through active surveillance instead of invasive treatments. Participants will undergo a percutaneous biopsy to confirm the diagnosis of RCC and will be monitored for tumor growth and progression over time. The study seeks to establish a standardized follow-up protocol and identify genetic markers that may indicate tumor aggressiveness, aiding in personalized management strategies for patients. A total of 400 patients across European countries will be included in this prospective study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Males or females, age ≥ 18 years
* Incidental diagnosis at imaging (ultrasonography, CT, MRI) of a solid renal mass \< 4 cm in maximum diameter.
* Histologically confirmed RCC by percutaneous needle biopsy at diagnosis. All RCC subtypes are eligible for the study.
* Patients unfit for active treatment due to advanced age, or co-morbidity, or choosing to avoid active treatment.
* Signed Informed consent.
* Preparedness to comply with percutaneous tumor biopsy and a close follow-up protocol

Exclusion Criteria:

* Renal tumors with a non-RCC histology (sarcomas, lymphomas, etc.).
* Presence of metastatic disease at diagnosis
* Tumor related symptoms at presentation.
* Patients with known genetic diseases associated with RCC (Von Hippel-Lindau, Birt-Hogg-Dubé, Hereditary Leiomyomatosis and Renal Cell Cancer, etc.).
* Patients unsuitable for biopsy due to need for concomitant anticoagulation or anti-platelet drug use which cannot be transiently discontinued.
* Patients unsuitable for biopsy due to tumor location or small tumor size.
* Patients with concurrent systemic treatment for another cancer.
* Patients with estimated life expectancy \< 1 year.

Where it's running

• Ospedale Maggiore della Carità
  Novara, Italy Recruiting

Study contacts

• Study coordinator: Alessandro Volpe, MD
• Email: alessandro.volpe@med.uniupo.it
• Phone: 0321373201

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.